This project aims to create a novel and comprehensive mechanism for managing informed consents and privacy authorizations for research called a "Research Permissions Management System" (RPMS) and implement it widely in the State of South Carolina (SC). It will simplify the collection and management of informed consent and privacy authorizations ("research permissions") that will accrue to an individual through their direct and indirect interactions with the research enterprise. Consumers are increasingly able to indicate their desire to participate in diverse aspects of research through a variety of new technologies and circumstances. For example, registering as a volunteer for clinical research via the Internet and agreeing to be contacted about specific research areas, are relatively new capabilities which bring legal, ethical, social and informatics challenges. This is placing a significant burden on institutions as they begin to integrate genomic and biospecimens with their clinical data for research purposes. Managing research permissions becomes even more complicated for distributed clinical trials networks, as they are often loose affiliations of collaborating institutions that are not mutual covered entities under the privacy laws like many fully-integrated healthcare delivery networks. However, clinical trials networks will increase in number and scope as the US reorganizes healthcare into networks-of-networks of hospitals. The current Grand Opportunity grant will allow the SC Center of Economic Excellence in Healthcare Quality (CHQ) to accelerate its planned clinical and translational research network by developing an RPMS for SC. We propose that this is feasible in a two-year period and will eventually significantly improve research investment, public health and healthcare in the State. We will do this through the use of sound informatics approaches, such as the development of an underpinning ontology for research permissions, use expert industry and academic partnerships, and demonstrate several novel technologies. It is intended to create a new "research permissions profile" that will enable users to manage their own data on the Internet in a significant advance in consumer choice. We believe this will increase trust and subject recruitment. The project will eventually lead to permissions framework that will be released to the general research community as open source code through the i2b2 project (Informatics for Integrating Biology and the Bedside), impacting clinical and translational research throughout the US. Health Sciences South Carolina (HSSC) was established as a result of the SC General Assembly's Research Centers of Economic Excellence Act. The goal of the Act is to create endowed chairs at the state's research universities stimulating a knowledge-based economy. HSSC is a collaborative of three principal research universities and four major health systems. It is a major sponsor of the Center for Healthcare Quality (CHQ) with a mission to create an integrated, statewide clinical trials network and facilitate clinical and translational research, impacting SC's major public health issues. PUBLIC HEALTH RELEVANCE: The current Grand Opportunity grant will allow the SC Center of Economic Excellence in Healthcare Quality (CHQ) to accelerate its planned clinical and translational research network by developing a Research Permissions Management System (RPMS) that will significantly increase growth and investment in biomedical research and development, improve public health, and impact healthcare delivery in South Carolina. The innovations proposed in this application will allow South Carolina to become a model for clinical and translational research with the ability for researchers to explore questions of the genomic associations of disease and their public health implications. By generalizing this work through the open source community, it has the potential to have proportionally more significance for accelerating clinical and translational research throughout the US.